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Results for "Trade secret protection"
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Patents and Trade Secrets Aren’t Mutually Exclusive: The Nuanced Nature of Trade Secret Protection

by | Aug 19, 2021 |

Addressing the nuanced nature of trade secret protection of patented products, the US Court of Appeals for the Seventh Circuit affirmed a district court’s trade secret protection determination, finding that the asserted trade secrets were not publicly disclosed and had been adequately protected. Life Spine, Inc. v. Aegis Spine, Inc., Case No. 21-1649 (7th Cir. Aug. 9, 2021) (St. Eve, J.)

The underlying conflict in this case has its roots in a short-lived business relationship between two companies specializing in selling spinal implant devices. Life Spine makes and sells a device called the ProLift Expandable Spacer System. Aegis Spine contracted with Life to distribute Life’s ProLift system to hospitals and surgeons for scheduled surgeries. Under the distribution agreement, Aegis was obligated to protect Life’s confidential information, act as a fiduciary for Life’s property and refrain from reverse engineering the ProLift system. Aegis did not abide by its contractual promises. It gave information about Life’s ProLift system to L&K Biomed, Aegis’s parent company and Life’s direct competitor. L&K used Life’s confidential information to develop a competing spinal implant device. Shortly after L&K’s device appeared on the market, Life sued Aegis for trade secret misappropriation and breach of the distribution agreement. The district court ruled in favor of Life, granting its motion for preliminary injunction against Aegis and its business partners, all of whom could no longer market the competing product. Aegis appealed.

Aegis argued that the injunction rested on the flawed legal conclusion that a company can have trade secret protection on a device that it publicly discloses through patents, displays and sales. The Seventh Circuit disagreed.

While the Court reaffirmed that there can be no trade secret protection in information available in the public domain, it found that such was not the nature of the information sought to be protected in this matter. Rather, the Seventh Circuit agreed with the district court that Life did not publicly disclose the specific information it sought to protect via patenting, displaying and selling its ProLift system.

The ProLift expandable spinal implant consists of the implant (or cage) component and an installer. The cage comprises an upper and lower endplate, a nose and base ramp and an expansion screw. The installer is used to insert the cage into a patient’s spine and expand the affected spinal disc height. Life considers “the precise dimension and measurements of the ProLift components and subcomponents and their interconnectivity” to be confidential trade secrets. The district court found that third parties are unable to access that precise dimensional information without first signing confidentiality agreements, and the information is not available in any of Life’s marketing materials (which include only dimensional approximations) or patents. Life’s ProLift system cannot be purchased by the general public or even handled at industry convention displays without Life’s close supervision. Instead, Life’s distributors sell ProLift directly to hospitals and surgeons for scheduled surgeries only.

The Seventh Circuit noted that “a limited disclosure” does not destroy all trade secret protection on a product, allowing a company [...]

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A Healthy Dose of Seeds: Unique Combination Trade Secrets Entitled to Protection

by | Nov 29, 2022 |

The US Court of Appeals for the Sixth Circuit upheld a jury verdict finding a dietary supplement company liable for misappropriating another company’s research and development (R&D) related to broccoli-seed extract. Caudill Seed & Warehouse Co., Inc. v. Jarrow Formulas, Inc., Case No. 21-5354 (6th Cir. Nov. 10, 2022) (per curiam) (Moore, J., concurring in part and dissenting in part). The decision addressed several issues relating to so-called “combination” trade secrets.

Caudill manufactures and sells various nutritional supplements, including a supplement made using broccoli-seed extract. Caudill sued Jarrow Formulas for trade secret misappropriation after its Director of Research Ken Ashurst left Caudill and joined Jarrow. Ashurst had led Caudill’s R&D efforts for nine years, including extensively researching the development of broccoli-seed derivatives and assembling a large body of research related to broccoli seeds. After he joined Jarrow, Ashurst delivered a curated collection of broccoli product research to Jarrow and helped it bring its own competing broccoli-seed extract supplement to the market in just four months.

The case proceeded to trial. The jury found that Caudill had a protectable trade secret; Jarrow misappropriated said trade secret; and Caudill was entitled to more than $2 million in actual losses, more than $400,000 in unjust enrichment damages, and exemplary damages. Jarrow moved for judgment as a matter of law and for a new trial. After the district court denied the motions, Jarrow appealed.

Jarrow argued that Caudill improperly asserted a “kitchen-sink theory” of trade secrets by broadly defining all its research activities as a single trade secret. Jarrow also argued that Caudill failed to show that it had acquired the alleged trade secret. Finally, Jarrow challenged the damages awards on legal grounds. The Sixth Circuit rejected each of Jarrow’s arguments on appeal.

The Sixth Circuit first found that Caudill properly defined its alleged trade secret as its “research and development on supplements, broccoli, and chemical compounds.” The Court treated Caudill’s alleged trade secret as a “combination” trade secret (i.e., a collection of elements that individually are generally known but are unique in combination.) The Court concluded that Caudill demonstrated it had assembled a unique collection of processes and information relating to its R&D process, and therefore, Caudill properly defined its entire R&D process as a trade secret. The Court rejected Jarrow’s argument that Caudill’s alleged trade secret mostly consisted of public domain materials on the basis that the materials were unique in combination.

The Sixth Circuit also rejected Jarrow’s argument that Caudill failed to show that Jarrow acquired and used the entire combination trade secret. The Court noted differing authority on whether a plaintiff alleging a combination trade secret must show acquisition and use of the entire combination but concluded that trade secret law does not require proving acquisition of “each atom” of the combination trade secret. The Court reasoned that when a trade secret consists of a “mass of public information” that has been collected, the defendant will always be able to identify some minute detail of the combination that it did [...]

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Patent by Secret Process: Perils of Pre-Patent Profiting

by | Aug 22, 2024 | ,

The US Court of Appeals for the Federal Circuit affirmed the International Trade Commission’s (ITC) determination that the asserted process patents were invalid under the America Invents Act (AIA) because products made using the patented process were sold more than one year before the patents’ effective filing dates. Celanese International Corporation, et al. v. International Trade Commission, Case No. 22-1827 (Fed. Cir. Aug. 12, 2024) (Reyna, Mayer, Cunningham, JJ.)

Celanese owns patents that cover a process for making the artificial sweetener acesulfame potassium (Ace-K). It was undisputed that Celanese’s patented process was in secret use in Europe and that Ace-K produced using this process had been sold in the United States before the patents’ effective filing dates. Under pre-AIA caselaw, such sales of products made using a secret process before the critical date would trigger the on-sale bar and invalidate any later-sought patent claims on that process. However, because Celanese’s patents had effective filing dates after March 15, 2013, the AIA rules applied. Thus, the case hinged on whether the AIA altered this rule.

In 2019, in Helsinn v. Teva, the Supreme Court addressed similar facts and confirmed that the Federal Circuit’s pre-AIA “on sale” case law, which established that “secret sales” could invalidate a patent, still applied. In Helsinn, the patentee had obtained a patent related to a fixed dose of palonosetron. Prior to the critical date, the patentee entered into a supply and purchase agreement with a third party that covered this same fixed dose of palonosetron. The Supreme Court concluded that Congress, by reenacting similar language in the AIA concerning the on-sale bar, appeared to have adopted the Federal Circuit’s pre-AIA interpretation of the on-sale bar. Accordingly, the Supreme Court held that, consistent with Federal Circuit pre-AIA precedent, an inventor’s prior sale of an invention to a third party can qualify as invalidating prior art even if the third party is obligated to keep the invention confidential.

However, unlike in Helsinn, where the claimed invention was the very subject of the commercial sale at issue, Celanese’s patents covered the secret process used to make Ace-K, and it was only the resulting Ace-K that was the subject of commercial sale – not the patented process itself. Although this distinction would not alter the outcome under pre-AIA law, Celanese averred that the AIA had revised the rules for this specific situation. To support its theory, Celanese referenced, among other things, the AIA’s use of the phrase “claimed invention” as opposed to simply “invention” as recited in pre-AIA discussion of the on-sale bar. According to Celanese, this change implied that the invention specifically “claimed” must be on sale to qualify as invalidating prior art.

The ITC rejected Celanese’s argument, concluding that the AIA did not alter the pre-AIA rule that “a patentee’s sale of an unpatented product made according to a secret method triggers the on-sale bar to patentability.” Accordingly, the ITC found that Celanese’s patents were invalid because Celanese sold Ace-K made using its secret process more [...]

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E for Effort? PI Analysis in Trade Secret Suit Riddled With Errors

by | Jun 27, 2024 |

The US Court of Appeals for the Federal Circuit reversed the granting of a sweeping preliminary injunction (PI) in a trade secret suit against a competitor, finding that the district court’s analysis failed to consider potentially dispositive issues and the requirements of the Defend Trade Secrets Act (DTSA). Insulet Corp. v. EOFlow, Co., Case No. 24-1137 (Fed. Cir. June 17, 2024) (Lourie, Prost, Stark, JJ.) Among other things, the district court:

  • Failed to consider whether the plaintiff’s claims were time-barred.
  • Used an incorrect definition of “trade secret.”
  • Based its irreparable harm analysis on an unsubstantiated fear of a competitor’s potential acquisition of the defendant.
  • Failed to meaningfully assess the balance of harm and the public interest factors.

Insulet and EOFlow are medical device manufacturers that make insulin pump patches. Insulet began developing its OmniPod product in the early 2000s and launched next-generation models in 2007 and 2013. EOFlow began developing its own insulin pump product, the EOPatch, in 2011 and began work on its second-generation product in 2017. Around the time that EOFlow began developing its second-generation device, four Insulet employees joined EOFlow.

In early 2023, Medtronic allegedly started a diligence process to acquire EOFlow. Shortly thereafter, Insulet sued EOFlow for trade secret misappropriation, seeking an injunction to bar all technical communications between EOFlow and Medtronic. The district court granted Insulet’s request, finding that Insulet was likely to succeed on its trade secret claim because EOFlow had hired former Insulet employees who retained Insulet’s confidential documents, and Medtronic’s intended acquisition of EOFlow would cause irreparable harm to Insulet. The injunction broadly prevented EOFlow from “manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on the Trade Secrets of Insulet.”

EOFlow appealed the injunction. EOFlow argued that the district court failed to address whether Insulet’s claim was time-barred under 18 U.S.C. § 1836(d) of the DTSA and to consider factors relevant to Insulet’s likelihood of success or meaningfully assess the balance of harm and public interest factors.

The Federal Circuit first observed that the district court had expressed no opinion regarding EOFlow’s § 1836(d) statute of limitations (SoL) argument, even though Insulet’s compliance with the SoL was a material factor that would significantly impact Insulet’s likelihood of success. This alone constituted an abuse of discretion meriting reversal.

The Federal Circuit found that even if the district court had addressed the SoL, the injunction was not adequately supported. The Federal Circuit explained that the district court had improperly and broadly defined “trade secret” as “any and all Confidential Information of Insulet,” where “Confidential Information” was defined by the district court to mean any materials marked “confidential” as well as any CAD files, drawings or specifications. The Federal Circuit explained that the district court should have required Insulet to define the allegedly misappropriated trade secrets with particularity. Instead, the district court allowed Insulet to “advance a hazy grouping of information” and stated that “it would be unfair to require at [...]

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In Good Hands: Compilation of Publicly Available Information Can Still Be a Trade Secret

by | Sep 21, 2023 |

The US Court of Appeals for the First Circuit affirmed a district court decision, finding that a compilation of customer-related information, even if publicly available, is a protectable trade secret. Allstate Insurance Co. v. Fougere, Case No. 22-1258 (1st Cir. Aug. 29, 2023) (Gelpi, Lynch, Thompson, JJ.)

Allstate hired two agents—James Fougere and Sarah Brody-Isbill—to sell the company’s auto and casualty insurance products in Massachusetts. In connection with their employment, both agents signed exclusive employment agreements that imposed numerous responsibilities, including an obligation to maintain information identified by Allstate as confidential, an undertaking not to misuse or improperly disclose the information and a promise to return the information to Allstate when their agency relationships terminated. Allstate eventually terminated its agreement with the agents because of noncompliance with Allstate regulations and Massachusetts state law.

After the agreements were terminated, Allstate believed the agents had retained confidential information belonging to Allstate and had been using it to solicit Allstate customers. Allstate ultimately learned that the agents had kept confidential Allstate spreadsheets that contained the names of thousands of Allstate customers, along with their renewal dates, premiums, types of insurance, Allstate policy numbers, driver’s license numbers, home addresses, phone numbers and email addresses.

Allstate filed suit against the former agents, bringing claims under both Massachusetts law and the federal Defend Trade Secrets Act (DTSA). The agents brought counterclaims under Massachusetts law, alleging that Allstate failed to provide adequate notice before their terminations, misappropriated information that belonged to the agents and wrongfully interfered with the agents’ contractual relations by engaging in bad-faith business practices. On summary judgment, the district court found that the agents misappropriated Allstate’s trade secrets and dismissed the agents’ counterclaims. The agents appealed.

The agents argued that the customer information was available from various publicly available sources and therefore did not constitute a trade secret. The First Circuit disagreed, explaining that the compilation of publicly available information could constitute trade secrets, particularly where attempts to duplicate that information would be “immensely difficult.” The Court also found that the factual record suggested that not all of the customer information was publicly available—and certainly not in the same compilation as it would be from Allstate.

The agents also argued that the customer information had no economic value. In analyzing this argument, the First Circuit looked to the employment agreements between the former agents and Allstate, which specifically stated that the misuse of Allstate’s confidential information would cause “irreparable damages” to Allstate. The employment agreements also provided a mechanism for terminated agents to sell their “economic interest” back to Allstate. The Court also relied on its finding that this sort of information would be valuable to Allstate’s competitors in attempting to market policies to Allstate customers so that the competitor could offer lower pricing. Taken together, the Court found that the customer data had economic value.

The agents next argued that Allstate had not sufficiently protected the customer information. The First Circuit, affirming the district court, found that Allstate had multiple protections in place. [...]

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If You Can’t Say a Secret under an NDA, Don’t Say It at All

by | Jul 27, 2023 |

Considering a trade secret misappropriation claim involving a business pitch that was not subject to a non-disclosure agreement (NDA), the US Court of Appeals for the Sixth Circuit affirmed a district court’s summary judgment grant for the accused party, finding that it had not acquired the information through a confidential relationship. Novus Grp., LLC v. Prudential Fin., Inc., Case No. 22-3736 (6th Cir. July 17, 2023) (Sutton, Boggs, Readler, JJ.)

Eric Seyboldt and Mark McCanney founded Novus Group to launch their financial product called the Transitions Beneficiary Income Rider. The pair developed the Rider to address the diminishing availability of retirement income vehicles—such as pension plans or 401k profit-sharing plans—for modern workers. In operation, the Rider guaranteed that, following a policyholder’s death, an insurance company would pay pension-style death-benefit proceeds to non-spouse beneficiaries throughout their lifetimes.

Novus partnered with financial product developers Genesis and Annexus to ensure that the Rider was feasible and to assist with a pitch to Novus’s target customer, Nationwide. These relationships were governed by two contracts with confidentiality provisions: the Genesis-Novus and Annexus-Novus contracts. Before Novus was formed, Genesis and Annexus had also created a joint organization, AnnGen, which had its own confidentiality agreement with Nationwide concerning AnnGen’s New Heights product (AnnGen-Nationwide contract). Prior to Novus’s pitch, Nationwide refused to sign an NDA and warned that Novus should “not disclose any confidential information.” Despite the lack of an NDA, Novus and Annexus pitched the Rider concept to Nationwide, which elected not to pursue the product.

After the unsuccessful pitch, two Nationwide employees who allegedly had access to information concerning Novus’s Rider product left Nationwide for Prudential. Shortly thereafter, Prudential launched Legacy Protection Plus, a death-benefit rider that was similar to Novus’s Rider product. Novus believed Prudential stole its Rider concept and sued Prudential for trade secret misappropriation. Prudential moved for summary judgment. The district court granted the motion. Novus appealed.

On appeal, the Sixth Circuit assumed the existence of a trade secret and its unauthorized use, focusing solely on whether Prudential had acquired Novus’s trade secret as a result of a confidential relationship or through improper means. The Court noted that Novus had not raised a theory of “improper means” in district court and thus had waived that argument.

The Sixth Circuit also found that the two Nationwide employees did not have a duty to Novus to maintain its information in the utmost secrecy. Novus argued on appeal that such a duty arose from the web of agreements among Annexus, Genesis, Novus, AnnGen and Nationwide. However, Nationwide was not a party to the Annexus-Novus and Genesis-Novus contracts and was not bound by them. Further, Novus was not a signatory to or third-party beneficiary of the AnnGen-Nationwide contract, which narrowly covered the New Heights product developed by AnnGen, rather than Novus’s Rider. Instead of creating a duty of confidentiality, these contracts demonstrated that Novus knew how to create a confidential relationship, yet declined to form one with Nationwide, which had explicitly refused to sign an NDA. The [...]

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Defend Trade Secrets Act Supports Sealing Information on Appeal

by | Jan 7, 2021 | ,

Addressing whether purported trade secret information ought to remain under seal on appeal, the US Court of Appeals for the Sixth Circuit ruled in a one-judge order that the Defend Trade Secrets Act (DTSA) provided a statutory basis that overcame the presumption of public access. Magnesium Machine, LLC v. Terves, LLC, Case No. 20-3779 (6th Cir. Dec. 10, 2020) (McKeague, J.)

This case presented the issue of what part of a record may be sealed on appeal—normally a routine question—in litigation that was anything but routine. According to the verified complaint, Magnesium Machine discovered a particular salt-based treatment for use on oil and gas tools. According to Magnesium, in the course of litigating a patent infringement suit against one of Magnesium’s suppliers, Terves and its counsel, McDonald Hopkins, obtained information reflective of Magnesium’s alleged trade secret from a third party pursuant to subpoena. Specifically, Magnesium claimed that particular language in a settlement agreement disclosed Magnesium’s trade secrets. The settlement agreement had been produced by the third party without any confidentiality designation. The complaint alleged violations of the federal DTSA and Oklahoma and Ohio state trade secrets acts.

Invoking the seizure provisions of the DTSA, Magnesium sought and obtained an ex parte order directing the US Marshals to seize Terves’s electronic equipment, including devices at Terves’ president’s home. That order did not last long. Following an evidentiary hearing (in which Terves participated) the day after the order was issued, the district court vacated the seizure order because Magnesium had not demonstrated misappropriation of a trade secret.

To appeal, Magnesium requested express findings of fact and conclusions of law. The district court explained that Terves and its lawyers subpoenaed materials in good faith, that the settlement agreement was produced without restriction (such as a confidentiality marking), that Terves’s lawyers did not impermissibly share the settlement agreement with Terves employees and that upon objection by Magnesium, Terves deleted its copies of the settlement agreement. Thereafter, on motions to dismiss, the district court concluded that Magnesium failed to allege misappropriation and that the litigation privilege protected Terves’ counsel.

Terves sought and obtained attorneys’ fees against Magnesium and its counsel for proceeding in bad faith. The district court found that Magnesium had every reason to know that its claims were baseless, because it was “well aware at the time the suit was filed that Defendants had received the allegedly secret information through legitimate discovery means and that it was provided to them without description.” Moreover, claiming that a three-word phrase in the settlement agreement purportedly disclosed trade secret information was “an intentional exaggeration/misrepresentation.” Indeed, other public statements had provided far more detail than the purportedly secret phrase, according to the district court.

On appeal, although Terves contended that the purported trade secret did not qualify as a secret, in the exercise of caution and on Magnesium’s request, Terves nonetheless sought to file a brief under seal. Judge David McKeague, acting on behalf of the Sixth Circuit, agreed that it was appropriate to seal the information, [...]

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Use of Infringing Product, Misappropriated Trade Secrets May Continue—for a Licensing Fee

by | Sep 3, 2020 |

The US Court of Appeals for the Sixth Circuit affirmed a district court’s stay of a permanent injunction against copyright infringement and trade secret misappropriation, permitting the infringer to continue use of an infringing product and misappropriated trade secrets but requiring the infringer to pay a licensing fee. ECIMOS, LLC v. Carrier Corp., Case Nos. 19-5436, -5519 (6th Cir. Aug. 21, 2020) (Boggs, J.).

Carrier sold HVAC systems. ECIMOS designed and sold a quality-control-testing system that assessed each HVAC unit at the end of Carrier’s assembly line. ECIMOS’s system consisted of a software program, associated hardware and a database that stored results of runtests performed by the system. Carrier paid ECIMOS to maintain and periodically upgrade its software system. ECIMOS licensed Carrier to use the system but prohibited unauthorized copying, distributing or creating derivative works based in whole or in part on the software.

Years into the relationship, ECIMOS upgraded its software to run on a new operating system. ECIMOS expected Carrier to agree to the proposed upgrade just as it had done previously. Unbeknownst to ECIMOS and without its consent, Carrier had already installed ECIMOS’s software directly onto the new operating system. Carrier started a venture with a third party, Amtec, to develop a new quality-control software and storage database to replace the ECIMOS system.

ECIMOS sued Carrier for violating the copyright on the ECIMOS system’s database, breaching the parties’ software-licensing agreement and misappropriating ECIMOS’s trade secrets. At trial, ECIMOS alleged that Carrier improperly shared ECIMOS’s copyrights and trade secrets with Amtec, allowing Amtec to develop a competing system. The jury agreed, finding that the competing system incorporated ECIMOS’s trade secrets. The jury determined that Carrier infringed the copyright on ECIMOS’s runtest database script source code, that ECIMOS held a trade secret in its software source code and its assembled hardware drawings and wiring diagrams, and that Carrier misappropriated those trade secrets by sharing them with Amtec. The jury awarded ECIMOS copyright and contract damages.

The district court also imposed a permanent injunction against Carrier’s use of the infringing Amtec database, but stayed the injunction until Carrier developed a noninfringing database. The court also enjoined Carrier from further disclosure of ECIMOS’s trade secrets, but did not enjoin Carrier from using those trade secrets. To the contrary, the district court appointed a special master to supervise the redesign and permitted Carrier to continue using the infringing database that incorporated ECIMOS’s trade secrets until the redesigned system was complete. The district court further required Carrier to pay ECIMOS the licensing fees that ECIMOS would have charged in the course of an ongoing, mutually agreeable licensing relationship. ECIMOS objected to the stay and appealed.

ECIMOS argued that the stay was an abuse of discretion, that the injunction should have prohibited Carrier from using (not just disclosing) ECIMOS’s trade secrets, and that the injunction should have prohibited Carrier’s disclosure and use of ECIMOS’s assembled hardware, not just the hardware drawings and wiring diagrams. The Sixth Circuit disagreed, affirming in full the district court’s [...]

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Calling All US IP Owners: Submit Your Comments on IP-Lax States

by | Jan 5, 2023 |

The Office of the US Trade Representative (USTR) seeks public commentary regarding countries that deny adequate and effective protection of intellectual property rights, or deny fair and equitable market access to US persons that rely on intellectual property protections. Comments are due by January 30, 2023.

Each year the USTR requests that intellectual property owners, stakeholders and other interested parties submit commentary regarding countries that weaken protections and benefits associated with intellectual property ownership and registration in the United States. The USTR interprets the feedback and compiles an annual report.

The USTR’s authority for such action arises out of Sections 301-305 of the Trade Act (19 U.S.C. §§ 2411-2415). These “Special 301 Provisions” require the USTR to determine which, if any, of the countries submitted by commenters should be identified as Priority Foreign Countries. In furtherance of this goal, the USTR maintains a Priority Watch List and a Watch List. The Special 301 listings and actions announced in the annual report are the result of intensive deliberations among all relevant agencies within the US government, which in turn are informed by extensive consultations with participating stakeholders, foreign governments, the US Congress and other interested parties.

The 2022 report identified a wide range of concerns, including the following:

  • Challenges with border and criminal enforcement against counterfeits, including in the online environment
  • High levels of online and broadcast piracy, including through illicit streaming devices
  • Inadequacies in trade secret protection and enforcement in China, Russia and other countries
  • Troubling “indigenous innovation” and forced technology transfer policies that may unfairly disadvantage US right holders in markets abroad
  • Other ongoing, systemic issues regarding intellectual property protection and enforcement, as well as market access, with many trading partners around the world.

The 2022 report listed the following countries on the Priority Watch List: Argentina, Chile, China, India, Indonesia, Russia and Venezuela. The report listed the following countries on the Watch List: Algeria, Barbados, Bolivia, Brazil, Canada, Colombia, Dominican Republic, Ecuador, Egypt, Guatemala, Mexico, Pakistan, Paraguay, Peru, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, Uzbekistan and Vietnam.

The USTR is soliciting comments for this year’s report via the online Federal eRulemaking Portal in lieu of an in-person hearing.  Commenters are encouraged to include detailed information, including the following:

  • Specific references to laws, regulations and policy statements, including innovation policies; executive, presidential or other orders; and administrative, court or other determinations that should factor into the review
  • Particular regions, provinces, states or other subdivisions of a country in which an act, policy or practice is believed to warrant special attention
  • Data, loss estimates and other information regarding the economic impact on the United States, US industry and US workforce caused by the denial of adequate and effective intellectual property protection.

Commentators should act now, as the window to submit public commentary ends on January 30, 2023. Keep an eye out for the 2023 report, which is scheduled for release on or around April 18, 2023.



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And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

by | Oct 6, 2022 |

In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit (characterizing the matter as the “entrepreneurial equivalent of musical chairs”) affirmed a dismissal of a trade secret claim against a foreign defendant but not against the related US entity, and found that the case qualified under Rule 54(b) for the “narrow exception” to the finality rule. Amyndas Pharmaceutical, SA v. Zealand Pharma A/S, Case No. 21-1781 (1st Cir. Sept. 2, 2022) (Barron, Selya, Kayatta, JJ.)

Amyndas is a Greek company with a US affiliate. It is a biotechnology firm that researches and develops therapeutics targeting a part of the immune system known as the complement system. One area of Amyndas’s research deals with “complement inhibitors.”

Amyndas’s research yielded compstatin, a peptide that selectively inhibits the C3 protein (which plays a role in activating the complement system). Amyndas also developed a related peptide (AMY-101) that targets that protein. Amyndas owns trade secrets and confidential information related to this work.

Zealand Pharma, a Danish biotechnology firm, contacted Amyndas about a potential partnership for the development of complement-related therapeutics. The firms entered into a confidential disclosure agreement (CDA) regarding information-sharing “for the purposes of evaluating a possible business/services relationship between the parties and their respective Affiliates.” Amyndas started giving Zealand Pharma access to confidential information (including confidential information about AMY-101). The firms also entered into a second CDA—with added protections—for “the evaluation or formation of a possible business and/or services and/or collaborative relationship.”

Both CDAs included an identical “Governing Law” provision stipulating that the CDAs would “be interpreted and governed by the laws of the country (applicable state) in which the defendant resides” and a forum-selection clause stipulating that “any dispute arising out of th[e CDA] shall be settled in the first instance by the venue of the defendant.”

Zealand Pharma also began its own research program focused on complement therapeutics. It did not inform Amyndas of this initiative. Although negotiations continued, the firms ultimately decided not to collaborate. Amyndas later terminated its information-sharing relationship with Zealand Pharma.

Zealand Pharma later formed Zealand US, a Delaware corporation. Without Amyndas’s knowledge or consent, Zealand Pharma also filed two European patent applications for compstatin analogues and later an international patent application designating the United States and claiming priority to the earlier  EU applications.

After the international applications were published, Amyndas learned that they described “compstatin analogues that are capable of binding to C3 protein and inhibiting complement activation,” which had been the focus of Amyndas’s research and a subject of Amyndas’s confidential information-sharing with Zealand Pharma.

The other defendant, Alexion, is an established player in the complement therapeutics field and a proprietor of Soliris, a complement inhibitor that targets a protein in the complement system. Soliris is approved by the US Food and Drug Administration (FDA) and previously was the only FDA-approved and clinically available [...]

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